Repetitive Transcranial Magnetic Stimulation for Dementia

NCT ID: NCT02621424

Last Updated: 2025-09-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-01
• Study Completion Date: 2025-09-16

Brief Summary

The purpose is to is to study if repetitive transcranial magnetic stimulation (rTMS) improves cognitive function in patients with neurodegenerative conditions which may manifest as mild to moderate cognitive impairment and, in late phase, dementia. This study also intends to investigate if the responses to rTMS intervention are either positively or negatively correlated with the initial severity of cognitive impairment.

Detailed Description

The primary hypothesis is that rTMS applied to the dorsolateral prefrontal cortex will lead to improved memory, language and executive function compared to patients who receive a sham, control treatment. The improvement is defined as having higher performance on the California Verbal Learning Test (CVLT-II). Secondary Hypotheses are that:

• 1: rTMS- will lead to higher performance on secondary cognitive measures relating to executive function and naming compared to performance by participants in the sham treatment group at the termination of treatment; and that
• 2: rTMS-induced memory improvement parallels changes in serum and cerebrospinal fluid (CSF) brain-derived neurotrophic factor (BDNF) levels after treatment.

Conditions

Dementia; Mild Cognitive Impairment

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

RTMS

repetitive transcranial magnetic stimulation

Group Type: EXPERIMENTAL

RTMS

Intervention Type: DEVICE

stimulation of the brain with magnetic pulses

sham

sham noise to block the sound of treatment

Group Type: SHAM_COMPARATOR

sham

Intervention Type: DEVICE

sham noise to block the sound of stimulation

Interventions

RTMS

stimulation of the brain with magnetic pulses

Intervention Type: DEVICE

sham

sham noise to block the sound of stimulation

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Veterans aged 55 years or older
• Diagnosed with Mild Cognitive Impairment (MCI) or dementia likely due to Alzheimer's disease.
• Ability to obtain a Motor Threshold, determined during the screening process.
• With an adequately stable condition and living environment to enable attendance at scheduled clinic visits.
• If on a prescription medication for cognition that medication dose will be stable for at least 4 weeks prior to randomization into the study and participant will be willing to remain on a stable regimen during the acute treatment phase.
• Able to read, verbalize understanding, and voluntarily sign the Informed Consent Form to be signed by the participant, or a designated legal representative when the participant lacks decision making capacity prior to participating in any study- specific procedures or assessments.

Exclusion Criteria

• Patients with prior exposure to rTMS or electroconvulsive therapy (ECT).
• Unable to safely withdraw, at least two weeks prior to treatment commencement, from medications that substantially increase the risk of having seizures.
• Have a cardiac pacemaker or a cochlear implant.
• Have an implanted device deep brain stimulation or metal in the brain
• Current substance abuse not including caffeine or nicotine as determined by patient report or chart review.
• Active current suicidal intent or plan as determined by patient report or chart review.
• Current or Prior history of a seizure disorder as determined by patient report or chart review
• Traumatic brain injury within the last two months
• Participation in another concurrent interventional clinical trial
• Known current psychosis as determined by patient report or chart review.
• Current or prior history of a mass lesion, cerebral infarct or other non-cognitive, active central nervous system (CNS) disease that would increase the risk for seizure.
• Not fluent in English or a hearing impairment severe enough to impair comprehension

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jauhtai J Cheng, MD

Role: PRINCIPAL_INVESTIGATOR

VA Palo Alto Health Care System, Palo Alto, CA

Locations

VA Palo Alto Health Care System, Palo Alto, CA

Palo Alto, California, United States

Countries

United States

References

Cheng J, Fairchild JK, McNerney MW, Noda A, Ashford JW, Suppes T, Chao SZ, Taylor J, Rosen AC, Durazzo TC, Lazzeroni LC, Yesavage J. Repetitive Transcranial Magnetic Stimulation as a Treatment for Veterans with Cognitive Impairment and Multiple Comorbidities. J Alzheimers Dis. 2022;85(4):1593-1600. doi: 10.3233/JAD-210349.

Reference Type: DERIVED

PMID: 34958013 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

RX14-009

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

E1889-P

Identifier Type: -

Identifier Source: org_study_id